Kornimate/medical-research-clean huggingface dataset:
efficacy and cost effectiveness of relaxation and response to chf

Conditions: Chronic Heart Failure

Summary: despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (chf) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. it is therefore important to find a cost effective non-pharmaceutical treatment to help chf patients manage the disease. the relaxation response has been found to be effective in managing chf-related conditions. with its favorable physiological changes, the relaxation response is likely to benefit chf patients.

background: despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (chf) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. it is therefore important to find a cost effective non-pharmaceutical treatment to help chf patients manage the disease. the relaxation response has been found to be effective in managing chf-related conditions. with its favorable physiological changes, the relaxation response is likely to benefit chf patients. objectives: 1. to evaluate the effects of a 15-week relaxation response intervention program on improving functional capacity and health-related quality of life as compared with an ongoing 15-week educational program for cardiac disease management, and a control group of usual cardiac care; 2. to identify the costs of conducting the intervention and the cardiac care education and the costs associated with cardiac care services; and to compare cost among three study groups. methods: this is a single-blind three-armed randomized trial in chf patients who receive care at the boston va medical center. enrolled patients are randomly assigned, with equal numbers, to one of the three study groups. outcomes include cardiac functional capacity and self-reported health-related quality of life. we also conduct a qualitative study to interview patients by phone about their experience in the study. status: this project has completed the data collection phase and is in the data analysis phase.

Eligibility criteria:
inclusion criteria: chf diagnosis, ny stage 2 or 3 exclusion criteria:
placebo-controlled study of the efficacy and safety of bg00012 in pediatric subjects with relapsing-remitting multiple sclerosis (rrms)

Conditions: Relapsing-Remitting Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis

Summary: the primary objective of the study is to assess the efficacy of oral bg00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (rrms). the secondary objectives of this study are to evaluate the safety and tolerability of bg00012 and to compare the effect of bg00012 with placebo on additional clinical and radiological measures of disease activity.


Eligibility criteria:
key inclusion criteria: * informed consent and assent as appropriate * must have a body weight of ≥30 kg * must have a diagnosis of rrms as defined by the revised consensus definition for pediatric multiple sclerosis (ms) * must be ambulatory with a converted krutzke baseline expanded disability status scale (edss) score between 0 and 5.0, inclusive key exclusion criteria: * primary progressive, secondary progressive, or progressive relapsing ms. * history of disorders mimicking ms, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders. * history of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (dmf) or fumaric acid esters. * prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab. * prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (iv) immunoglobulin, plasmapheresis or cytapheresis. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: randomized ages 10-17 pediatrics placebo controlled relapse-remitting multiple sclerosis safety efficacy bg00012
to evaluate the effectiveness(immunogenicity) and safety of 'gc1107' administered intramuscularly in healthy children

Conditions: Bacterial Infections

Summary: the purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'gc1107' administered intramuscularly in healthy children

randomized, double blind, multicenter, phase ⅱ/ⅲ study

Eligibility criteria:
inclusion criteria: * healthy korean children(age: 10 \~ 17) * in the case of step1 (for step 1) 11\~12 years * who got the basic vaccination(5 times vaccination of diphtheria and tetanus until 6 years old.) * subjects willing to provide written informed consent and able to comply with the requirements for the study or informed consent was obtained from the subject's legal guardian exclusion criteria: * subjects with antitoxin of diphtheria and tetanus ≥1.0iu/ml (elisa) * only applicable in step 1 * subjects who have not recovered from the acute disease within 2 weeks * who has experienced the temporary platelet decrease or has the medical history of neurologic complication * who has the medical history of allergic disease related to the components of investigational drug * who has experienced the severe adverse events for the diphtheria and tetanus vaccination * who got the vaccination of diphtheria and tetanus within 5 years * who has not recovered from the acute disease within 2 weeks * who got the treatment of blood product within 3 months * who got the immunoglobulin should have the wash-out period * who be infected from the diphtheria and tetanus * subjects who are scheduled to participate in other clinical trial studies during the study. * current participation in a clinical study involving any other drugs including vaccine within 4 weeks of enrollment of the study vaccine. * subjects who have participated in any other clinical trials within 4 weeks of the administration of the study * subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment * subjects with a history of chronic disease obstacles to the study. * subjects who have episode of acute febrile (at least 37.5) after injection of vaccine during the study * subject who have plan of operation during the study. * individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
safety and immunogenicity study of rift valley fever vaccine, inactivated

Conditions: Rift Valley Fever

Summary: this study is designed to determine the safety and immunogenicity of an inactivated rift valley fever (rvf) vaccine in adults

the primary objectives are to assess safety of rift valley fever (rvf) vaccine, inactivated (tsi-gsd 200) and to assess immunogenicity of rift valley fever (rvf) vaccine, inactivated (tsi-gsd 200). the secondary objective is to assess incidence of rvf infection in vaccinated personnel

Eligibility criteria:
inclusion criteria: 1. at least 18 years old. 2. females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours before each vaccination. females will be advised not to become pregnant for 3 months after the primary series and each booster dose. 3. females must not be breast-feeding. 4. subject must be at risk for exposure to rvf virus. 5. subject must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests in their charts and be medically cleared for participation by an investigator. examinations or tests to qualify for enrollment may be repeated at the discretion of the investigators. 6. subject must sign and date the approved informed consent document. 7. for initiation of primary series, rvf prnt80 \<1:10. 8. for re-entry into this protocol or rollover from an earlier rvf protocol to receive a booster, rvf prnt80 \<1:40 within past 1 year exclusion criteria: 1. older than 65 years of age for the primary series vaccination (able to receive booster doses if no other contraindications). 2. clinically significant abnormal lab results, including evidence of hepatitis c, hepatitis b carrier state, or elevated (2 times normal) liver function tests. 3. personal history of immunodeficiency or current treatment with immunosuppressive medication. 4. confirmed positive human immunodeficiency virus (hiv) titer. 5. any medical condition that, at the discretion of the physician, may jeopardize the safety of the subject. 6. any serious or life-threatening allergies to any component of the vaccine: formalin human serum albumin neomycin streptomycin fetal rhesus lung cells rvf virus inactivated 7. administration of any investigational new drug (ind) product or any vaccine within the 28 days before rvf vaccination. 8. any unresolved adverse event resulting from a previous immunization.

Keywords: hemorrhagic fever viral infections neurologic diseases arbovirus infections rvf
eus-guided biliary drainage versus percutanenous transhepatic biliary darinage for malignant biliary obstruction after failed ercp

Conditions: Cholestasis, Extrahepatic

Summary: although ercp is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ercp may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., roux-en-y anastomosis), or complex hilar biliary strictures. in such cases, percutaneous transhepatic biliary drainage (ptbd) is an useful alternative. however, ptbd had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (qol) of terminally ill patients. since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of eus-guided biliary drainage (eus-bd) suggested that it was a feasible and effective alternative in patients with failed conventional ercp stenting. the potential benefits of eus-bd include one-stage procedure in ercp unit, and internal drainage for avoiding long-term external drainage in cases where external ptbd drainage catheters cannot be internalized, thus significantly improving the qol of terminally ill patients, and possibly lower morbidity than ptbd or surgery. up to date, only a few case series of eus-bd with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.10-21 there has been no comparative study between the outcomes of ptbd and eus-bd focusing on the qol, cost-effectiveness, and complications. the researchers investigated the technical success of eus-bd and ptbd in patients with malignant biliary obstruction after failed conventional ercp as a prospective randomized comparative study in multicenters. secondary endpoints were the cost-effectiveness and complications rates between eus-bd and ptbd.


Eligibility criteria:
inclusion criteria: * presence of unresectable malignant distal biliary obstruction (greater 2cm than distal to hilum, i.e., pancreatic cancer, common bile duct cancer, ampulla of vater cancer, gallbladder cancer, duodenal cancer, and metastatic biliary obstruction) * failed conventional ercp and inaccessible papilla because of accompanying duodenal obstruction, periampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (billroth ii operation, roux-an-y operation.) * histologic or cytologic diagnosis of malignancy, d) a karnofsky index of ≧30%, e) no serious or uncontrolled medical illness * provided informed consent. exclusion criteria: * patient age of less than 18 years * uncorrectable coagulopathy * history of allergy to radiocontrast agents * refusal to participate in this study.
evolution of visual impairment during pseudoxanthoma elasticum

Conditions: Pseudoxanthoma Elasticum

Summary: pseudoxanthoma elasticum is a disease whom frequency is estimated about 1/50000 to 1/100 000. there is a female preponderance with a sex-ratio of 2:1. pxe is transmitted according either to an autosomal dominant mode or to an autosomal recessive one. mutations in the abcc6 gene on chromosome 16p13.1 have recently been identified causing pxe. the elastic fibers slowly become mineralized mainly in the skin, the eyes, and the cardiovascular system. pxe is a multisystem disease that includes a spectrum of clinical manifestations affecting the skin, the eye or the cardiovascular system as well as other tissues. it can be responsible for severe and life threatening complications. skin changes are usually the first manifestations and begin in early childhood. the vital prognosis of pxe depends on the severity of the cardiovascular lesions that could be responsible for sudden death in children and young adults. ocular manifestations are quite constant and include chorioretinal scarring, pigmentary changes or angioid streaks. the natural evolution of the angioid streaks leads to their enlargement or to the occurrence of subfoveal choroidal neovascularizations and hemorrhages leaving macular scares. a self-monitoring is recommended since early treatment of subfoveal cnv is the only way to minimize their pejorative consequences. the gold standard treatment of the cnv consists in the photocoagulation. new therapeutics has been developed including photodynamic therapy or intravitreal injection of anti-angiogenic agents and they seems to be effective to reduce the immediate complications of a limited cnv. this evolution explains that 50 to 70 % of the patients have a poor vision or legal blindness of one or both eyes. however, little is known about the age of occurrence of visual impairment in pxe patients. that is the reason why we decided to review the ophthalmologic status and visual history of our population of pxe patients according to their age.

a retrospective review of all cases of pxe patients referred by the department of genetics should be performed. this ophthalmologic examination has been conducted as part of the usual follow up for such pxe patients or for the needs of a treatment of complications of angioid streaks such as cnv complications. as we studied the age of poor vision occurrence, we propose to take in account the first examination when a best-corrected visual acuity (bcva) under 20/50 was observed. all past medical events obtains from the data of the patients will be recorded, especially ophthalmologic ones.

Eligibility criteria:
inclusion criteria: * pseudoxanthoma elasticum confirmed by the department of genetics according to the usual clinical, histological or genetic criterion. exclusion criteria: * no pseudoxanthoma elasticum

Keywords: pseudoxanthoma elasticum visual acuity choroidal neovascularization angioid streaks
modified thoracoabdominal nerve block(m-tapa) in total laparoscopic hysterectomies

Conditions: Pain,Postoperative

Summary: the aim of the study is comparing the postoperative effects of ultrasound-guided modified perichondrial approach to thoracoabdominal nerves (m-tapa) block for postoperative pain control after total laparoscopic hysterectomy.

pain is one of the most common problems seen in the postoperative period in patients who underwent total laparoscopic hysterectomy. multimodal analgesia methods are used in postoperative pain management. nerve blocks, which are an important component of multimodal analgesia, have an important place in postoperative analgesia management today. local anesthetic infiltration at the trocar site is the most classical nerve block method that has been used for a long time as a part of multimodal analgesia in laparoscopic surgeries. modified tapa block applied with ultrasound guidance; it is a regional block affecting both the anterior and lateral branches of the thoracoabdominal nerves with a perichondrial approach. it is used in total laparoscopic hysterectomies.

Eligibility criteria:
inclusion criteria: * ages 18-65 * elective cases * asa i-iii functional status * body mass index (bmi)\<35 * total laparoscopic hysterectomy planned with general anesthesia * no contraindications for m-tapa block to be applied * cases that give written and verbal consent for participation in the study will be included. exclusion criteria: * conversion to open surgery * development of perioperative complications (due to surgery and/or anesthesia) * coagulation disorder * infection at the injection site * allergy to local anesthesia * those who used any painkillers in the preoperative 24 hours * those who did not agree to participate in the study

Keywords: m-tapa, post-operative pain, total laparoscopyc histerectomy
assessment of pulmonary congestion during cardiac hemodynamic stress testing

Conditions: Dyspnea; Heart Failure With Preserved Ejection Fraction

Summary: the aim of this study is to utilize lung ultrasound to detect the development of extravascular lung water in patients undergoing clinically indicated invasive hemodynamic exercise stress testing for symptomatic shortness of breath. the study will correlate the lung ultrasound findings with cardiac hemodynamics and measurements of extravascular lung water in an effort to better understand the pathophysiology of exertional dyspnea.

exercise induced elevation of left ventricular (lv) filling pressures can be the source of chronic dyspnea. ultimately, high lv filling pressure leads to the development of extravascular lung water (evlw) which can cause symptoms of dyspnea. lung ultrasound (lus) is a highly feasible, non-invasive procedure that is extremely sensitive for detecting evlw. the sonographic signature of evlw is a reverberation artifact called a "b-line". the study will evaluate the etiology of sonographic b-lines using invasive hemodynamic catheterization while simultaneously measuring the amount of evlw present during exercise stress testing using transpulmonary thermodilution. the study aim is to demonstrate that the severity of evlw, assessed by number of b-lines, will correlate with lv filling pressures. in addition, the study will test the hypothesis that patients demonstrating dynamic increases in sonographic b-lines with exercise will also display more severe symptoms of dyspnea, altered ventilatory mechanics (higher ratio of minute ventilation to carbon dioxide production (ve/vco2)), and reduced aerobic capacity (lower peak oxygen consumption (vo2)).

Eligibility criteria:
inclusion criteria: * all adult patients (≥18 years) who are referred for invasive cardiac hemodynamic assessment * patients who have the capacity to understand and consent for the research study exclusion criteria: * patients with known interstitial lung disease or pulmonary fibrosis

Keywords: dyspnea heart failure with preserved ejection fraction pulmonary edema lung ultrasound extravascular lung water
effectiveness of desensitisation and pain neuroscience education in patients with carpal tunnel syndrome with nosiplastic pain

Conditions: Carpal Tunnel Syndrome

Summary: the aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).

people between the ages of 18-65, diagnosed with carpal tunnel sedrome, who are suitable for the nosiplastic pain phenotype and who volunteer to participate in the study will be included. the 7 steps in the clinical criteria/rating system determined by the international association for the study of pain (iasp) for nosiplastic pain will be applied to patients with cts. after determining the predominant pain phenotype in patients with cts, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. one group (group 1) will receive desensitisation and the other group (group 2) will receive desensitisation and pain neuroscience education. numerical rating scale (nrs) will be used for pain assessment. boston carpal tunnel questionnaire - symptom severity scale will be used for symptom severity assessment and boston carpal tunnel questionnaire - functional status scale will be used for functional status assessment. pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. the pain catastrophising scale and the tampa kinesiophobia scale will be administered to the patients. normality of the data distribution will be assessed using the shapiro-wilk test. fischer's exact test and chi-square test will be used to verify the relationship between categorical variables. a mixed model anova will be performed on 2 (group 1 and group 2) x 3 (time: baseline, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.

Eligibility criteria:
inclusion criteria: * being diagnosed with cts * being suitable for the nosiplastic pain phenotype * being between the ages of 18-65 * volunteering to participate in the study exclusion criteria: * having systemic inflammatory disease * having a disease that may cause polyneuropathy such as diabetes mellitus * having a pacemaker * having a disease affecting the central nervous system * having cervical radiculopathy * history of previous operation or local steroid injection due to cts * hypersensitivity to heat and cold
epileptic seizure in epilepsy patients after sars-cov-2 vaccination

Conditions: Epileptic Seizures Related to Drugs; SARS-CoV-2 Acute Respiratory Disease; Vaccine Adverse Reaction

Summary: background and objectives: seizure attack is one of adverse effects of vaccination in epileptic patients, the risk of which after severe acute respiratory syndrome coronavirus 2 (sars-cov-2) inoculation was elucidated in the present study. methods: a self-controlled case series study was designed to examine the association between vaccination and epileptic seizure. a total of 240 epilepsy patients were included who were vaccinated with inactive sars-cov-2 vaccines (sinovac life sciences and lanzhou institute of biological products) and admitted to outpatient clinics from july 2021 to december 2021. poisson analysis was performed to estimate the relative incidence rate of epileptic seizure in risk periods (day 1-7, 8-21 and 1-21 after first-dose vaccination) compared to basal level in control period.


Eligibility criteria:
inclusion criteria: * male or female participants * have a diagnosis of epilepsy by the end of the study * have received at least one dose of inactive sars-cov-2 vaccine (sinovac life sciences and sinopharm group) exclusion criteria: * non-epilepsy patients vaccinated with inactive sars-cov-2 vaccine * epilepsy patients administrated with non-inactive vaccine * unvaccinated epilepsy patients

Keywords: epilepsy patient risk of seizure sars-cov-2 vaccine